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NCT04016233 · ClinicalTrials.gov registry record · Phase 1
Tenofovir Rectal Douche to Prevent HIV Transmission
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT04016233: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT04016233 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04016233, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
DREAM-03 is an early phase-1, open label study to compare the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of 3 sequences of tenofovir (TFV) and non-medicated douches. The overall goal is to inform the design of an extended safety study of an on-demand and behaviorally congruent TFV douche to confer protection from HIV acquisition in an outpatient pre-RAI context.
Primary Outcome
Colonic tissue cell TFV-DP concentrations (femtomoles/million cells) will be measured after each study douche sequence administration, based on the individual participant's sampling schedule, on Day 1 (at 1 hour, 3 hours, or 6 hours post dose), Day 2 (24 hours post dose), Day 4 (72 hours post dose), or Day 8 (168 hours post dose).
Interventions
- DRUG Tenofovir douche
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-01-10 |
| Est. Completion | 2021-04-27 |
| Phase | Phase 1 |
What the finished NCT04016233 record still lists
NCT04016233 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Tenofovir douche is the first listed.
NCT04016233 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04016233 about?
NCT04016233 is a clinical study titled "Tenofovir Rectal Douche to Prevent HIV Transmission". DREAM-03 is an early phase-1, open label study to compare the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of 3 sequences of tenofovir (TFV) and non-medicated douches. The overall goal is to inform the design of an extended safety study of an on-demand and behaviorally con...
What is the current status of trial NCT04016233?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2020-01-10. Estimated completion is 2021-04-27.
What interventions are being tested in trial NCT04016233?
The interventions under investigation include: Tenofovir douche (DRUG).
Who is sponsoring clinical trial NCT04016233?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04016233's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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